India’s proposed pact with Europe may choke its generic drug exports, health rights activists fear

BMJ 2011; 342 doi: (Published 07 March 2011) Cite this as: BMJ 2011;342:d1480
  1. Ganapati Mudur
  1. 1New Delhi

International aid agencies and patients’ groups from India and several Asian countries have urged the Indian government to reject a free trade agreement it is negotiating with the European Union. The agreement may undermine India’s capacity to produce inexpensive generic drugs, they say.

Indian patients’ groups for people with cancer and HIV and health rights activists from Cambodia, Indonesia, Malaysia, Nepal, and Thailand marched in Delhi and met with Indian government officials this week while Indian and European diplomats negotiated the text of the agreement behind closed doors in Brussels.

The concerns stem from leaked sections of the text showing that the EU wants India to accept a “data exclusivity” provision that would force India’s drug manufacturers to submit their own data on safety and effectiveness to be able to register their generic products. It will oblige manufacturers of generic drugs to repeat clinical trials on products …

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